Spots Global Cancer Trial Database for Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
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Trial Identification
Brief Title: Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
Official Title: A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids
Study ID: NCT01328067
Study Description
Brief Summary: The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids. Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy. All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment. Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
St. Mary's Hospital, London, , United Kingdom
Contact Details
Name: Wady Gedroyc, Prof.
Affiliation: St Mary's Hospital, London
Role: PRINCIPAL_INVESTIGATOR
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